Prevalence of Lipodystrophy Syndrome and Its Role as Cause of Metabolic Disturbances

NCT02614027 | Completed

• 2 other identifiers: 460/15EC 460/15
• Study Type: observational
• Target: 276
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the prevalence of lipodystrophy syndrome in patients receiving currently available antiretroviral drugs, and the prevalence of associated metabolic syndrome in HIV-infected patients with a previous diagnosis of lipodystrophy syndrome, according to the severity of fat accumulation and antiretroviral drug use.

Conditions

Lipodystrophy; Metabolic Syndrome

Outcome Measures

Primary Outcomes (2)

• Prevalence of metabolic syndrome as defined by the NCEP-ATP III (National Cholesterol Education Programme-Adult Treatment Panel III)

  Prevalence of the different components of this syndrome: Abdominal obesity: waist circumference ≥102 cm in men and ≥88 cm in women, hypertriglyceridemia: ≥150 mg/dl (1.695 mmol/l), low HDL-C: \<40 mg/dl in men and \<50 mg/dl in women, high blood pressure (BP): \>130/85 mmHg, and high fasting glucose: \>110 mg/dl.

  3 months

• Prevalence of lipodystrophy syndrome as defined by changes in fat by DXA

  Comparison of changes in visceral and subcutaneous fat during current antiretroviral therapy for patients receiving current antiretroviral regimens and who never received thymidine analogues, didanosine, lopinavir, indinavir, or nelfinavir.

  6 meses

Secondary Outcomes (1)

• Value of dual X-ray absorptiometry (DXA) in predicting the development of lipodystrophy and metabolic syndrome

  3 months

Interventions

Evaluation of metabolic syndrome OTHER

Evaluation and analytical determinations of the different components of the syndrome

Evaluation of changes in fat by DXA while on current therapy OTHER

Comparison of changes in fat (visceral and subcutaneous) by dual X-ray absorptiometry since therapy initiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV-infected patients on antiretroviral therapy with current drugs (excluding drugs previously associated with fat disturbance), and HIV-infected patients with previous evaluation of lipodystrophy syndrome in different severity, as determined by DXA and questionnaire.

You may qualify if:

• HIV infection
• Older than 18 years
• Receiving first or second antiretroviral regimen or
• Previous evaluation and classification of lipodystrophy syndrome

You may not qualify if:

• Pregnancy
• Patients who had received antiretroviral drugs known to produce fat disturbances (for lipodystrophy prevalence objective)

Sponsors & Collaborators

• Asociacion para el Estudio de las Enfermedades Infecciosas: lead

Study Sites (1)

Ramon y Cajal Hospital

Madrid, 28034, Spain

Location

MeSH Terms

Conditions

Lipodystrophy; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders

Study Officials

• Jose L Casado, MD

  Ramon y Cajal Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2015
• First Posted: November 25, 2015
• Study Start: February 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: June 1, 2018
• Last Updated: July 2, 2018

Record last verified: 2018-06

Locations

ES (1)